Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Apple Diagnostic Products — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

40 daysmedian FDA review time
120 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K844287ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDIIApple Diagnostic Products1985-01-07630
K843745ADP ANA APPLEZYMEApple Diagnostic Products1984-10-25300
K843120APPLELISA CHLAMYDIA TRACHOMATIS ANTIApple Diagnostic Products1984-09-12350
K842707ADP NDNA IFA TESTApple Diagnostic Products1984-08-21400
K842183ADP ANA IFA TESTApple Diagnostic Products1984-06-22210
K834241ANA APPLELISAApple Diagnostic Products1984-04-041200
K834242ADP IFA TEST FOR CHLAMYDIAE TRACHOMATISApple Diagnostic Products1984-03-02870

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda